AdvaMed Reveals its Policy Wish List for New Congress

AdvaMed, the Medtech Association, released its “Medical Innovation Agenda for the 119th Congress this week, urging lawmakers to support policies that help improve the efficiency, transparency, and predictability of healthcare technology regulation.

“In 2022, I said we were in the golden age of medical technology innovation. That is truer today than it was then. What’s more, we have the opportunity to work together to ensure that when history looks back on this era, people will call it the platinum age of medical technology innovation,” AdvaMed President/CEO Scott Whitaker wrote in a letter to Congress introducing the Medical Innovation Agenda. “That is how quickly our industry is moving: From AI, which is already helping doctors to make more accurate cancer diagnoses, to wearable and implantable technologies that communicate in real time with doctors. From literal tattoos that monitor and transmit vital data to a patient’s care team, to robotic surgeries administered from thousands of miles away.  

The Medical Innovation Agenda reflects the breadth and variety of medtech and AdvaMed’s recent expansion to encompass the entire industry. AdvaMed’s latest Medical Imaging and Digital Health Tech divisions reflect the prominent role of advanced imaging and digital health products, increasingly artificial intelligence (AI)-enabled, in serving patients and clinicians.

“From a policy perspective, how can we best set up our doctors, nurses, and medical technology innovators for success? How can we ensure patients live longer, healthier, and happier lives? What can you do as a champion for patients and medical innovation as a member of Congress, working with us as the Medtech Association?” Whitaker’s letter reads. “I invite you to read our Medical Innovation Agenda for the 119th Congress through the eyes of patients. Would these bipartisan policies improve their quality of life, or extend their lives, or even save them? Our view at AdvaMed, the Medtech Association, is that each and every one of them would. And we ask you not only to support them—but to actively promote them.”

The Medical Innovation Agenda includes legislative and policy proposals that:

• Support the modernization of CMS to strengthen America’s position as the global leader in medtech innovation
• Expand patient access to breakthrough medical technologies 
• Ensure tax law keeps pace with medtech innovation
• Harness artificial intelligence’s power to improve outcomes and increase patient access to innovative technology
• Strengthen the U.S. medtech industry’s global leadership position
• Secure American medtech supply chain resilience
• Protect and strengthen the critical role of medical imaging in early diagnosis and patient outcomes
• Strengthen the regulatory process to ensure the latest medical technologies reach every patient
• Ensure the U.S. Food and Drug Administration (FDA) keeps pace with the speed of medtech innovation 
• Ensure patient access to accurate diagnostic tests 
• Boost next-generation medtech innovation through America’s startups

AdvaMed’s priorities also reflect the evolving policy needs of rapidly advancing mainstays in medtech-powered diagnoses, treatment, and condition monitoring and management, from in-vitro tests to surgical tools to diabetes management systems to radiation therapy. All areas require policy modernization to ensure access to every patient who could benefit from the latest safe, effective medtech.

To help modernize the Centers for Medicare & Medicaid Services (CMS), AdvaMed is asking legislators to reintroduce and pass versions of several bills from the previous Congress:

• H.R. 5389, the National Coverage Determination Transparency Act, requiring the U.S. Secretary of Health and Human Services to take action on national coverage determination (NCD) applications within 30 days of submission.
• H.R. 5388, the Supporting Innovation for Seniors Act, which would require Medicare Advantage plans to cover the same technologies covered by traditional Medicare.
• H.R. 5392, the Timely Access to Coverage Decisions Act, which creates a timeline for contractors reviewing local coverage determinations.
• H.R. 7939, the Patient Access to Innovative New Technologies Act of 2024, which would provide conditional approval for breakthrough devices to receive new technology add-on payment (NTAP) the first quarter of the year in which the device received FDA approval, clearance, or authorization.

The policy recommendations supporting small businesses and startups respond to the fact that more than 80% of medtech companies fall in that category, often developing a single product that could provide a revolutionary solution for patients but struggling to stay afloat.

Learn more about the specifics of the agenda and the ways in which it will benefit U.S. patients, innovation, and the medtech economy here.